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Why understanding this product is important:
Good Manufacturing Practices (GMPs) for Active Pharmaceutical Ingredients (APIs) has traditionally been addressed by the FDA by 21 CFR Part 211, which does not specifically speak to the API (or drug substance) component of finished drug products. This document was created to fulfil the need for specific guidance with regards to GMPs for APIs. Failure to meet these requirements is a significant source of observations during regulatory inspections by FDA or global regulators of manufacturers and or of sponsors that use contract manufacturers and the contract manufacturers themselves. Even if sponsors do not manufacture the APIs or final products in-house, they are still responsible for the APIs being manufactured using GMPs, as per the ICH Q7 guidance document. Therefore, contract manufacturers should attend to verify that they are in compliance with ICH Q7. As defined in ICH Q7, manufacturing is defined to include all operations of receipt of materials, production, packaging,repackaging, labelling, relabelling, quality control, release, storage and distribution of APIs and the related controls.
Failure to comply with gmps (for apis as is the subject of webinar) but also applies to gmps for final product, etc: a product that fails to comply with cgmps is considered adulterated. Also: fda can issue a warning letter or initiate other regulatory actions against a company that fails to comply with current good manufacturing practice regulations. Failure to comply with cgmps can also lead to a decision by fda not to approve an application to market a drug.
Recommended for all levels- all levels, from individuals that are new to gmps to those with advanced knowledge of gmps,would benefit from taking this course. As these requirements are necessary for the sponsors, as they are responsible for contact manufacturing organization compliance (as are the cmos themselves), even if they are not physically manufacturing the apis themselves. Quality is the responsibility of all pharma employees, not just the people in quality dept.
More about topic:
Good Manufacturing Practices for Active Pharmaceutical Ingredients, ICH Q7, was developed by ICH (which includes the EU, US and Japan), in conjunction with an Expert Working Group (EWG) comprised of other global organizations and nations.Therefore, ICH Q7 for the regulation of Good Manufacturing Practices for APIs is largely accepted worldwide, though each sponsor should verify the applicability of this guidance document to each country that they are marketing their product.The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes (such as recombinant DNA, hybridomas, etc.). See NOTE below for the APIs included in this guidance document and those which are EXCLUDED from the ICH Q7, GMPs for APIs guidance document. Therefore, they will not be addressed in this webinar.
Areas Covered in the Session:
- Roles of Quality Management, Quality personnel, Production management and Production personnel in ensuring GMP manufacture of apis under an appropriate system for managing quality will be covered. Sops required for items, as stated in the guidance document, will be included.
- Buildings and Facilities- including design and construction, utilities,water, etc.
- Process Equipment, including design and or construction, maintenance, cleaning,calibration, computerized systems.
- Documentation and Records, including Documentation system andspecifications, Equipment records, Records of raw materials, intermediates, APIlabelling and Packaging materials, Master Production, Batch Production and LabProduction records and the review of batch records.
- Materials Management, receipt and or quarantine, Sampling and testing of incoming production materials, storage
- Packaging and or identification labelling of apis and Intermediates
- Storage and Distribution.
- Laboratory Controls, including testing of intermediates and apis,Validation of Analytical Procedures, C of As, Stability Monitoring, Expiry dating.
- Validation Policy, Documentation, Qualification, Process validation,Validation Approaches, etc.
- Change Control, Complaints and Recalls, Rejection and Re-use of Materials.
- Specific Guidance for apis Manufactured by Cell Culture and or Fermentation
- ICH Q7 states that the following documents should be used in combination with its use: ICH Q11, Development and Manufacture of Drug Substances(Chemical Entities and Biotechnological and or Biological Entities), with regards to the principles for development and manufacturing. In addition, ICH Q9, Quality Risk Management and ICH Q10, Pharmaceutical Quality Systems should be used with this document. The Pharmaceutical Quality System (PQS), as per ICH Q10,refers to the recommended, globally-harmonized comprehensive quality system, that emphasizes establishing and maintaining a state of control and, through use of the change management system, facilitates continual improvements by making appropriate science and risk-based changes to improve product quality, implement appropriate process improvements, introduce innovations and result in reductions in variability,throughout the life cycle of the product. Due to time constraints, the PQS and ICH Q11 will be introduced very briefly, so that attendees will be aware of their recommended use, provided with some basic knowledge and be able to seek further information as necessary.
Who will benefit:
- Quality management (VP of QA, QA and or QC Manager, QA Director)
- Quality Assurance Associate and or Specialist
- Regulatory Affairs Management (VP and or Director and or Manager of RA)
- Quality Auditors
- Production personnel (Production specialists, Production manager, supervisor)
- Compliance professionals
- Quality Engineer, Quality Engineering Manager
- Validation Engineer, Validation specialist, Manager of Validation Department
- Contract manufacturing organizations (that do contract manufacturing, testing of APIs, handling, distribution, etc. of pharmaceutical or bio pharmaceutical products as covered in this document), sponsors (pharma companies that use contract manufacturers to manufacture pharmaceutical products) but they own and sell pharma or bio pharma products covered in this guidance as described in this document.
Stephanie Cooke is the President and CEO of Cooke Consulting, Inc. Stephanie uses her roughly 20 years of experience to provide global consulting services in various areas of Regulatory Affairs, Quality Assurance and validation for pharmaceutical,biological and or biotech products, medical device, combination drug and device and nutraceutical firms. Her broad-based experience includes preparation of regulatory dossiers for human and animal pharmaceutical (chemical entities and biologically-based drugs), biotech products, drug and device combination products and medical devices in all stages of development (INDs, NDAs, BLAs,post-marketing supplements such as CBEs, Prior approval supplements, orphandrug designation and related submissions, 510ks, PMAs and HDEs).
She also has extensive QA and validation experience, successfully hosting many regulatory audits conducted by FDA, ISO and other international regulatory bodies (Irish Medical Board and others), training personnel on hosting audits by global regulatory bodies, as well as establishing auditing programs to qualify contract manufacturers and vendors of raw materials, APIs, etc. and product release experience in manufacturing environments and for companies using contract manufacturers, responsibility for establishing and maintaining Quality systems for all product types, establishing stability programs, as well as preparation and performance of process validation(s), including sterilization validation(s) (EtO, steam, gamma), aseptic processing, qualification of clean rooms and water systems and manufacturing process validation. Stephanie has been involved in the development of drugs, including biologics, biotech products and medical devices, from product concept through post-approval maintenance including requirements for submissions for various regions and countries, process validation requirements, etc. and has considerable project management experience.
Prior to beginning Cooke Consulting, Inc.about 9 years ago, Stephanie worked for Sciele Pharma from 2005-2009 as the VP of Regulatory Affairs, Quality Assurance and Validation. She also held various senior RA, QA and validation positions at Merial, Bayer(Visible Genetics), Cryolife, Theragenics and other pharmaceutical, biotech and medical device companies, after beginning in industry as a lab tech and working as a certified as a Microbiologist. She has a BS in Biology and an M.S. in Molecular Genetics and Biochemistry from Georgia State University.